KR19990072160A - Medical valve with tire seal - Google Patents

Abstract

The medical valve has a body comprising a wall structure forming an internal cavity having a proximal end and a distal end. The proximal end has an opening large enough to receive the tip of the dispensing end of the medical device that delivers fluid therethrough. The valve also has a spike with a tip received in the cavity and at least one hole disposed away from the tip. The spike has a passageway in communication with a hole that allows fluid to flow through the interior. The valve also has an elastic seal in the cavity surrounding the spikes. The seal is adapted to move in a compressed state when the tip of the medical instrument is inserted into the opening. The seal has sufficient elasticity to return to a reduced pressure state when removing the tip of the medical instrument from the opening. Besides. The seal has at least two tires in contact with spikes proximate the aperture, thereby preventing the flow of fluid through the valve when the seal is in a reduced pressure state.

Description

Medical valve with tire seal

The manipulation and medical setting of parenteral dosing fluids in hospitals typically employs the use of connectors and adapters to facilitate the movement of fluid between two points. Most fluid connectors and adapters employ needles to penetrate the septum covering the sterile perfusion or through the septum of the fluid's chemical container. These connectors and adapters often have mechanical or moving parts. Easily passing fluid through the connector and adapter is important for patient construction, and the connector and adapter must be operated reliably and repeatedly. Failure of the adapter and connector during use may endanger the patient's life. The more mechanical or moving parts, such as springs or diaphragms, the easier it is to operate improperly. Improper operation may cause air embolism in the patient. Thus, the fewer mechanical components, the better these connectors are reliable and acceptable to the medical field.

Many connectors or valves, especially connectors or valves employing various mechanical components, have a relatively large volume of fluid space therein. "Voided spaces" in such devices will prevent the precise loading of fluid volumes and provide an opportunity for contamination if the device is disconnected. Connectors and adapters often include valves that allow or impede the flow of fluid along the path of fluid movement. Most of these contain needles that penetrate sterile seals. These connectors are adapted to promote fluid flow in one direction. This means that the fluid line should have connectors and tubes arranged in opposite directions. These connectors must be adjusted frequently, for example if the valve is inadvertently assembled in a direction that cannot promote fluid flow. This adjustment can be cumbersome to handle, thus increasing both the risk of contamination and the time required to establish a fluid connection.

Metal needles adopted as part of a connector device often have through holes disposed in the tips of the needles. The connection of the flow line and the valve involves penetrating the needle through the sealing septum. The through hole disposed in the needle tip can be placed in the center of the septum and allow free particles to enter the flow line. This can be fatal to the patient. These through holes may easily be blocked by material from the septum. In addition, the use of a pointed needle may cause the septum to deteriorate.

Reusable connectors and adapters are suitable for medical applications because the components are often detached from the fluid line connected to the patient. However, reusable connectors are difficult to maintain aseptic. Some caps cover the connector to maintain sterility. These caps are often lost and are often not used because they are difficult to obtain as needed.

The closed patient access system, which adopts a valve device in easy-to-use and non-overlapping patient or medical device, maintains sufficient durability even after several adjustments, and prevents leakage of fluid at high pressures. To maintain and provide significant benefits in the medical field.

The present invention relates to a closed patient access system that is automatically resealed after dosing with standard medical instruments directly connected to the system without the use of intermediate needles, caps or adapters. An anisotropic valve is used that, when compressed by a medical device, penetrates the seal to open the valve and maintains a fluid leak-tight seal even under high pressure and repeated use and eliminates void space.

The preferred embodiment showing all the features of the present invention will be described in detail. These embodiments illustrate new and unknown methods and valves and medical device indicators of the present invention and methods of using the same, as shown in the accompanying drawings for illustration. Similar parts in these figures are shown using like numerals.

1 is a perspective view of a first embodiment of a valve according to the present invention;

FIG. 2 is an exploded perspective view of the valve shown in FIG. 1, showing the spike and seal and body or housing components of the present invention. FIG.

3 is a longitudinal cross-sectional view of the assembled valve of FIG.

Fig. 4 shows a state before the seal is compressed and is a schematic longitudinal cross-sectional view of the assembled valve of Fig. 1.

FIG. 5 shows a valve under seal compression, which is a schematic longitudinal cross-sectional view similar to FIG.

Figure 6 is a perspective view of a second embodiment of a valve according to the present invention.

7 is a longitudinal cross-sectional view of the valve of FIG.

8 is a schematic diagram illustrating an ANSI feed end of a medical device compressing a seal of a valve.

Fig. 9 is a side view showing an embodiment of the seal partly in cross section.

10 is a longitudinal sectional view of the assembled valve of FIG. 1 using the seal of FIG.

11 is a longitudinal sectional view of the assembled valve of FIG. 1 using yet another embodiment of a seal.

12 is a longitudinal sectional view of the assembled valve of FIG. 1 using yet another embodiment of a seal.

13 is a longitudinal sectional view of yet another embodiment of a seal.

FIG. 14 is a longitudinal sectional view of the seal shown in FIG. 13 used with the spike device shown in FIG.

Figure 15 is a partial longitudinal sectional view of still another embodiment of the seal of the present invention.

FIG. 16 is a longitudinal sectional view showing a state after assembly of the valve assembled using the seal of FIG.

17 is a longitudinal sectional view showing a state after assembly of a valve assembled using another embodiment of the seal.

Figure 18 is a longitudinal sectional view showing a state after assembly of a valve assembled using another embodiment of the seal.

Fig. 19 is a side view showing a state after assembly of the seal and spike shown in Fig. 14 connected to the main body or housing shown in Figs. 20 and 21;

20 is a sectional view taken along line 20-20 of FIG.

Fig. 21 is a perspective view showing the housing shown in Fig. 19 in a broken plane to show the common wall structure incorporating the seal shown in Figs. 13 and 14;

FIG. 22 is an enlarged sectional view taken along line 22-22 in FIG.

Figure 23 is a longitudinal sectional view of yet another preferred embodiment of a seal.

FIG. 24 is a partial cross sectional view showing a state after assembly of a valve assembled using another preferred embodiment of the seal and spike of FIG.

Figure 25 shows a groove in the housing and is a partial cross sectional view of the valve of Figure 24;

FIG. 26A shows a groove in the housing and is a plan view of the valve of FIG.

FIG. 26B is a plan view of another preferred embodiment of a valve with a channel shown in phantom through the sidewall of the valve. FIG.

Figure 27 shows a channel, and is a partial cross sectional view of the valve of Figure 26b.

Figure 28 is a perspective view of the housing in broken plane to illustrate a cavity wall structure with a seal therein including a groove in the housing.

29 is an elevational view of a preferred embodiment of a housing with a channel through the housing wall shown in phantom.

The valve of this invention is not specifically limited and used only for a preferable use. The most representative embodiments will be briefly described without departing from the scope of the invention as set forth in the claims below. After considering this point of view, it will be understood that the following detailed description of suitable embodiments provides that the features of the present invention are safe, reliable, repeatable, easy to manufacture and use, and provide long life without failure. .

Suitable embodiments of seals used in the present invention include a series of O-ring elements that overlap one another to form an integral structure. The O-ring element gradually increases in diameter, and the small diameter element is disposed near the proximal end of the cavity. The O-ring element closest to the seal proximal end contacts the spike wall near the through hole when the seal is under compression and prevents fluid from leaking from inside the spike through the base opening in the housing. At least the adjacent intermediate O-rings should also be in contact with the spike adjacent the through hole. This design prevents the fluid from applying sufficient pressure on the slit to push the slit open even when the seal is in a reduced pressure state. In a suitable embodiment, the fluid is disposed in the spike, between the seal and the seal away from the through hole, without opening the slit in the seal cap. The seal is arranged such that the fluid pushes the seal upward slightly and raises the first and second O rings away from the spikes, and the O ring element closest to the first and second elements is raised. Contact with the spikes to prevent fluid from flowing out of the cap and out of the valve. Maintaining this contact around the spikes allows fluid pressure on the slit to open the slit and avoid leakage of the valve.

According to another feature of the invention, the housing is provided with a fluid escape space, such as a groove or channel, to allow fluid contained between the exterior of the seal and the housing to escape during seal compression. In one embodiment, the proximal end of the housing is provided with at least one groove extending from the proximal end of the housing to the recess received in the housing. During seal compaction, fluid between the seal exterior and the housing is forced out of the valve through the proximal end of the housing through the groove and toward the base side. In another embodiment, the channel is provided as a fluid escape space through the side wall of the housing. As the seal is compressed, fluid between the outside of the seal and the housing moves out of the valve through the channel. As will be described in detail later, several advantages are provided by providing a groove or channel to allow fluid between the exterior of the seal and the housing sidewall to escape during compression of the seal.

The term "proximal end" refers to spike tip 32 at or near FIGS. 2-5, 10-12, 14, 16, 24, 25, and 27, and spike tip 60 of FIG. ) Or near, and the ends of the valves and other components in or near the seal cap 92 of FIGS. 8, 9, 13-19, 23, 24, 25, and 27. . The term "end" means the opposite end of the valve, spike tip or seal. As used herein, “medical device” is known to those skilled in the art and includes any medical device that facilitates the passage of fluids, especially liquids. Examples of medical devices include, but are not limited to tubing, conduits, syringes, IV sets (peripheral and centerline), piggyback lines, medical valves, and other components. Medical devices are commercially available in standard sizes. Thus, one or both ends of the valve may be provided with fittings to accommodate such standard size medical devices.

The valve is closed and the patient has access to a system that automatically reseals after drug administration using a medical device that connects directly to the system without requiring any intermediate needles, caps or adapters. Two-way valves use a reusable seal that is repeatedly perforated by a spike that is housed and protected rather than exposed metal needles. The valve delivers the fluid, in particular the liquid, while keeping it sanitized. The valve is easy to use and can be locked in place. After use, the valve is reduced in a known manner using appropriate materials to maintain disinfection. The structure of the valve keeps the needle from accidentally stabbing. As will be described in detail later, the valve is useful as a medical connector or adapter that allows liquid to flow from a sealed container.

A first feature of the invention is that the valve has a body comprising a wall structure forming an internal cavity having a proximal end and a distal end. The cavity has an open space in which the seal is pushed out, and preferably has a plurality of radial recesses in the wall structure adjacent to the seal to accommodate expansion of the seal upon compression. The proximal end has an opening large enough to receive the distal end of the medical device that delivers the fluid through the distal end. In most applications, the transfer end of the medical device is tapered inwardly so that the wall structure and the tapered transfer end fit snugly together when the transfer end is inserted into the opening. The common base is designed to fit snugly against the ANSI (US Standards Research Institute, Washington, D.C.) standard end of the medical device. Typically, the device can be a syringe, a connector or inlet / outlet of an IV set, or one of several conduits used for medical purposes.

A second feature is that the spike has a tip with at least one hole located at or near itself, and a passage communicating with the hole to allow fluid to flow through the hole. Preferably, the hole is on the side of the spike adjacent the tip and extends long and has a size of at least 18 gauges. One or more holes are suitable for several applications, with three symmetrically located holes inside the proximal end. The spike is seated inside the cavity and the tip is embedded in a seal cap located at the proximal end of the seal. The tip of the spike is blunted or rounded to avoid weakening of the seal from repeated puncturing by the spike. The spikes include at least one rib that allows air to be introduced into the space between the seal and the spikes so that the opening can be easily sealed when the device is removed. The spikes take a substantially conical shape, and the seal has a cone-shaped cavity therein that matches the shape of the spikes.

A third feature is that the resilient seal is configured to move into a compressed state when the tip of the medical device is inserted into the opening and to return to the decompressed state when the tip is removed. The compressed seal has a section that completely fills the cavity portion adjacent to the opening. In the compressed state, the seal is pushed from the opening to the cavity by the transfer end of the medical device. The seal portion, known as the seal cap, may have a precut slit in which the proximal end of the spike is embedded. The feed end and the seal of the medical device are configured to engage so that there is no dead space between the feed end and the seal when the tip of the spike punctures the seal. Thus, using the present invention, all of the prescribed dosage is delivered to the patient without the predetermined amount being collected in the dead space of the valve. In some situations, such as when administering chemotherapy or treating a child, it may be necessary to deliver the correct amount of medication.

As shown in Figs. 1 and 2, the valve 10 of the first embodiment includes a valve body or housing 12, a spike element 24 and a seal 36. Seal 36 is made of a flexible material that is flexible, inert, impermeable to fluid, and can be easily perforated by spikes 26.

In the valve embodiment of FIG. 13 showing the alternative shaped seal 36d, the seal 36d has a wedge cutting slit 11 at its adjacent end. This provides a very small orifice through which the tip 32 of the spike element 24 can easily pass, or provides a fluid tight seal upon retraction of the spike element. These three elements are assembled as shown in FIG. 3 with spike element 24 enclosed to prevent accidental sticking. 2 shows how the housing 12, seal 36 and spike element 24 are attached without the need to use any adhesive or other binder or adhesion method. The mechanical connection providing the fluid tight cover is achieved as described below. As shown in FIGS. 4 and 5, the seal 36 moves within the housing 12 and moves the tip 32 of the spike element 24 to allow fluid to flow through the valve 10. Perforated by spike element 24 to expose.

1, one preferred embodiment of the housing 12 has a longitudinal skirt 16 and preferably a cylindrical upper conduit 20. The skirt 16 is integral with the upper conduit 20 and is connected to the conduit by an annular ring 14. The inner conduit 18 is preferably cylindrical and somewhat tapered. The inner conduit 18 and the upper conduit 20 have hollow tubes aligned to be in fluid communication with each other when the spike element 24 punctures the seal 36. At the top of the conduit 20 is an annular lip 25 surrounding the circular opening 25a. (See FIG. 2).

In a first embodiment of the valve, the upper conduit 20 is designed to receive a tip or nose 48 of an ANSI standard syringe 46 (shown in FIGS. 4 and 5). However, it is envisaged that the outer diameter of the upper conduit 20 can be of any size to accommodate attachments of other connector devices. Effectively, the proximal end of the upper conduit 20 may have a locking mechanism that easily locks the valve 10 to various medical equipment. For example, according to FIG. 1, the locking ear 22 near the adjacent lip 25 of the housing 12 preferably includes any replaceable luer—wherein the housing 12 is commonly known to those skilled in the art. It is provided to be locked into a Luer-Lock device. For example, according to FIG. 19, a conventional luer-lock thread 180 can be provided on the outer diameter of the upper conduit 20.

2, spike element 24 has an inner conduit 18 at its distal end and a hollow spike 26 integral with the inner conduit at its adjacent end. The inner conduit 18 and the spike 26 provide a continuous passage for the fluid during use. An annular cuff 28 on the middle portion of spike element 24 is integral with and connects to inner conduit 18 and to spike 26. As shown in FIG. 3, the rim 28a of the cuff 28 abuts the bottom of the inner ring 14, and an annular recess 28b snaps into the annular groove 14b at the bottom of the ring. Has The cuff 28 performs two functions. First, it acts as an attachment device to the bottom of the annular ring 14. Second, it acts as a support and attachment for the seal 36.

The hollow spike 26 has the shape of a tapered cone that terminates with a sharp tip 32. Preferably, the protruding ridge 30 protrudes along the length of the spike. These protruding ridges 30 preferably extend from the surface of the spikes between 0.2 and 2.0 mm. Ridge 30 is preferably aligned along the length of the spike as shown in FIG. These ridges 30 act to break any vacuum generated when spike 26 is sealed, as described below. Corrections to the alignment and operation of the ridges are discussed below in conjunction with these functions. At the distal end of the spike tip 32 there is at least one longitudinal through hole 34 to allow fluid communication between the inner conduit 18 and the upper conduit 20. Preferably there will be three through holes 34 within approximately 10 mm, more preferably 5 mm, from spike tip 32. These through holes 34 may have any size, but the larger the size of the through holes is, the larger the fluid flow rate through the valve 10 becomes. In a preferred embodiment for the valve, the size of the through hole 34 is 18 gauge, which provides three times the flow rate of the standard 18 gauge needle.

The seal 36 preferably has a sealing cap 40 having a generally flat upper surface 40b, an outwardly tapered sidewall 38, and a lower lip 42. Its interior is hollow to provide a conical cavity 37 (as shown in FIG. 3). Thus, the seal 36 slides easily over the spike element 24 to fit well into the cavity 37. The sealing lip 42 is positioned into the annular cuff 28 and is wedge shaped between the cuff and the bottom of the ring 14. In use, longitudinal grooves 43 (shown in FIG. 2) are present along the length of the seal 36 that provide air pockets that facilitate compression of the seal 36. The grooves 43 may have varying shapes or sizes to facilitate sealing compression. In the first valve embodiment, there is a single groove 43 completely enclosing the seal 36 between the sealing cap 40 and the lip 42.

The base of the seal 36 has a width such that the seal lip 42 fits well into the annular cuff 28. The hollow interior or cavity 37 of the seal 36 (shown in FIG. 3) is preferably tapered to coincide with the interior of the shape of the spike 24 and the spike 24 at the end of the sealing cap 40. Has a wall portion 44 in contact with it. The exterior of the seal 36 is sized and shaped to fit into the upper conduit 20 of the housing 12. The cap 40 reseals the valve 10 when the upper surface 40b is adjacent to the through hole 34. Preferably, the cap 40 nearly fills the opening 25 above the conduit 20. Thus, after assembly, the upper surface 40b of the sealing cap 40 has the same height as the lip 25, so that the lip 25 and the sealing cap 40 are free of alcohol without leakage of the disinfectant into the valve 10. Or with other fungicides. It is important that the surface 40b be exposed so that it can be cleaned with a disinfectant.

As best shown in FIG. 3, spike 24 with inoculated inner conduit 18 is coupled to housing 12 through engagement of an outer portion of annular cuff 28 with an inner portion of annular ring 14. Is attached to. Although not required, these two parts are not necessarily limited to any one of a variety of methods known to those skilled in the art including, but not limited to, heat sealing methods, glue bonding methods, pressure locking methods, bonding methods, and the like. It may be attached. The seal 36 fits into the annular cuff 28 and is held in place along the inner portion of the annular ring 14 of the housing 12 by an inner lip 27. The length of the spike 24 is such that after assembly the tip of the spike is below the plane defined by the lip 25 of the housing 12. Preferably, spike tip 32 ranges from approximately 1.3335 to 2.54 cm (0.525 to 1 inch) below lip 25 of housing 12. The seal 36 fits well against the spikes 24 and is substantially flush with the lip 25 of the housing 12. Thus, spike tip 32 is thus embedded into sealing cap 40 prior to use, and may be spaced approximately 0.025 cm (0.025 in) from sealing cap 40 when valve 10 is in the closed position. The inner conduit 18 is partially blocked by the longitudinal skirt 16 of the housing 12 (as shown in FIGS. 1-3). The inner surface of the bell shaped skirt 16 preferably has protruding threads 44 as an optional locking mechanism for pulling medical equipment.

In addition, other medical devices may be fit against the outside of the inner conduit 18 without being directly connected with the protruding screws 44.

In use, the valve is designed to be suitable as a two-way valve. The direction of the valve is independent of the fluid flow and depends on the direction of the connection first. Thus, the valve can be used as a valve connector for piggyback in the venous center or circumference in either direction. Parenteral fluid is administered to the patient through the tube to allow liquid to flow from the container through the penetrating element to the patient. The container is replaced frequently and another fluid bottle is added. The valves disclosed herein are intended to interconnect medical devices along a route of fluid administration to a patient. However, such a valve can be used in any case where a resealable fluid valve is required. In use, a properly sized connector is coupled to the inner conduit 18. As mentioned above, locking may be accomplished by a luer lock mechanism, an interference fit or any other locking mechanism known to those skilled in the art. Thus, in one embodiment, the fluid passes from the inner conduit 18 into the spike 26. However, the fluid flow is locked in position by the seal 36.

4 and 5 show valve operation. In FIG. 4, the medical instrument connecting to the adjacent end of the valve 10 is a syringe 46. However, such a connection device may be any medical device known in the art. The nose 48 of the syringe 46 is located on the seal cap 40 inside the lip 25 of the housing 12. Application of pressure on the syringe 46 in the direction of the arrow as shown in FIG. 4 generates pressure on the seal cap 40. As a result, downward pressure forces the seal 36. This urges the tip 32 of the spike 26 through the seal cap 40 to expose the through hole 34. The groove 38 facilitates compression. Thus, depending on whether the fluid is inhaled from the patient or the medicine is injected into the patient, the fluid can flow into the syringe and vice versa. FIG. 5 shows the valve 10 opened by insertion of the nose 48 of the syringe 46 into the opening 25a. Retracting the syringe plunger 49 in the syringe 46 creates a vacuum for sucking fluid through the valve 10 into the syringe. In intravenous applications, valve 10 may be directed to the position shown in FIGS. 4 and 5, or the valve may be rotated 180 ° to allow fluid to flow in the opposite direction.

Upon removal of the syringe from the spike 26, as shown in FIG. 4, the seal 36 returns to its original shape and is free to cover the through hole 34. The ability of the seal 36 to return to its original shape is also reinforced by the protruding ridges 30 formed on the outer surface of the spikes. During compression, a vacuum may be formed in the area between the spike 26 and the seal 36, thereby preventing the seal 36 from returning to its original position. The protruding ridge 30 allows air to pass along the spike / seal body interface to prevent vacuum formation and allows free return of the seal 36. The ability of the seal 36 to deform and return back to its original position is i) to immediately stop fluid flow through the valve 10 and ii) to cover the grooved spike 26 to maintain sterility. Iii) reducing the risk of spikes inadvertently penetrating another object or person. In addition, since there is no movable part except the seal in the valve 10, the possibility of the valve 10 not functioning when the seal is pushed downward is reduced.

Preferably, the through hole 34 is positioned relatively low on the spike 26. Thus, the through hole 34 is sealed relatively early in the process of returning the seal to its original shape when the valve 10 is closed. In one preferred embodiment of the valve, the through hole 34 is located 1.8 mm (0.075 in) below the spike tip 32 (see FIG. 2). In addition, the through hole 34 is sealed even when the seal 36 is not completely returned to the original shape shown in FIG. In addition, the ability of the seal 36 to return to its original position allows for reuse of the valve 10. After separation, before reuse, the surface of the perforated seal cap 940 is essentially flush with the housing 12. Thus, these same height surfaces can be easily sterilized with alcohol or other surface decontamination material. Skirt 16 and top conduit 20 provide good shielding of both connections from the surrounding environment to protect the sterility of the connections. In addition, both the skirt 16 and the upper conduit 20 function as a collection reservoir to prevent fluid from dropping from the valve 10 during operation.

A cover cap (not shown) is provided to engage the upper conduit 20 as an additional guard on the seal face until use. However, since the seal 36 can be wiped with a disinfectant after each use, this cover cap does not need to remain sterile. Because of the reversibility of the seal 36, the valve 10 has particular advantages as a connector valve that allows fluid communication between two fluid lines. Thus, using the valve disclosed herein, the valve connects the second fluid line with the first fluid line. The reversibility of the valve 10 allows, for example, a plurality of fluid lines to be added continuously to the fluid line directly connected to the vein of the patient. Since the valve is easily sterilizable and sealable, fluid lines can be added or removed without separating the venous contact.

The valve 10 is preferably made of hard plastic, such as ABS plastic, although the valve may be made of other medical inert materials known in the art. The spike element 24 is preferably made of the same material as the housing 12. However, a stronger material, such as a polycarbonate material, may be desirable for the spike element 24 so that the spike element 24 can penetrate various connecting partitions and seals. A particular advantage of this valve is that the use of the metal needle is unnecessary. This dramatically reduces the risk of skin penetration during use and manufacture. In addition, the upper conduit 20 functions as a shield for the spike 26 so that the contact of the spike 26 with the skin is further reduced. The spike 26 only needs to be strong enough to penetrate the sealing cap 40, and to be strong enough to penetrate the connecting partition wall if necessary.

In the embodiment of the valve shown in FIGS. 2-4, the through hole 34 is located far from the spike tip 32. First, the position of the through hole 34 facilitates resealing of the valve 10 after use. Secondly, if the through hole is located at the spike tip 32, the hole 34 is capable of introducing the sealant particles into the fluid flow by closing the seal cap 40 and blocking the hole 34. Thus, the longitudinal placement of the through holes away from the spike tip 34 prevents the introduction of particles into the fluid path and / or blockage of the through holes 34. In addition, the number and diameter of the through holes 34 can be adjusted to accommodate various flow rates.

In a preferred embodiment of the valve, the desired velocity of the fluid through the through hole 34 is equal to or greater than the flow rate through the 18 gauge needle. Of course, through holes larger than 18 gauge further promote fluid flow rate.

An important advantage of the valve 10 is that the valve has a very small dead space, so that the volume of liquid entering the valve 10 is substantially equivalent to the volume of fluid exiting the valve 10. In addition, the overall equivalent fluid volume of the valve is so small that the volume of fluid flowing through the system to be in fluid communication with a medical device, such as syringe 46, is substantially zero.

In another preferred embodiment of the valve shown in Figures 6 and 7, a disposable sterile adapter valve 50 is provided to function as a resealable lid to a container of fluid (not shown). Thus, the fluid may be removed from the fluid container or may flow from the container into a medical device configured to receive the fluid in a sterile manner.

6 shows an adapter valve 50 having a body that includes an adapter skirt 52. The adapter skirt 52 is preferably slip fit over the opening of the container. The skirt 52 can be of any size to suit containers of various sizes. Preferably, longitudinal slits 54 are provided at at least one point along the length of the skirt to ensure a slip fit between the skirt 52 and the container. Preferably, the tubular chamber 56 extends upwardly from the skirt 52 and is similar in configuration and design to the upper conduit 20 of the first preferred valve embodiment. Similar to the first valve embodiment, the proximal end of the valve may preferably contain a locking mechanism 59 comprising a Luer-Lock device or other locking device known to those skilled in the art.

As shown in FIG. 7, spike 58 extends upward through tubular chamber 56. Preferably, spike tip 60 is indented from proximal lip 62 of tubular chamber 56. In the closed position, the tip 60 is covered by a seal 64 that is substantially the same as the seal 36. The protruding ridges 66 and the seal grooves 68 facilitate sealing and promote closure after use. Thus, in the closed position shown in Fig. 7, the seal 64 covers the through hole 70 to prevent fluid outflow from the container. Adapter valve 50 includes a second spike 72 pointing in a direction opposite to spike 58. These spikes 52, 72 are in fluid communication with each other. The spike 72 extends downward on the inside of the adapter skirt 52. The two spikes preferably form one component of the valve 50 and the skirt 52 and the upper chamber form the second component. These two components can be assembled in a similar manner to the valve 10. The spike 72 has a longitudinal through hole 74 and a tip 76 like the spike 58. The through hole 74 is located inward of the tip 76. Thus, the adapter valve 50 can be used with a container containing a sterilizing agent having a lid or partition seal at the opening of the container. Examples of containers with such seals for use with the valve include dosing bottles for intramuscular syringe antibiotic containers and the like. However, the valve 50 may be configured to be adapted to containers for various medicaments or other fluids with its own seals and locking mechanisms. The drug in this type of container is preferably maintained under sterile conditions and the nature of the drug is such that a large number of aliquots are removed intermittently over time. Once the medicament is reconstituted, any cover on the container opening is removed to expose the rubber septum during use. The adapter valve 50 is placed on the partition wall and direct pressure is applied to penetrate the end spike 72 through the partition wall into the container. A syringe or the like can then be applied with the first preferred valve embodiment as shown in FIG. 4 to withdraw fluid from the container. The pressure of the nose 48 over the spikes pushes the spike tip 60 through the seal 64. At the same time, the seal 64 is compressed. Compression is received by the seal groove 68. The fluid is withdrawn from the container and the syringe is removed from the spike 58. The release of the pressure applied to the seal 64 causes the seal 64 to return to its original shape. The spike ridge 66 encourages movement of the seal 64.

Often, the ingredients contained within a container are those that can be lyophilized upon purchase. Lyophilized components require reconstitution before use. If the medicament requires reconstitution before use, sterile water, saline or other liquid may be introduced into the container prior to extraction of the liquid. The bidirectionality of the valve allows such use without any special modifications. After the syringe is removed, the adapter valve 50 is automatically sealed. Thereafter, the aliquot can be removed from the container by syringe or the like. Alcohol or other suitable surface disinfectant may be used to wipe the lip 62 and the seal 64 before each use. Similar to the first valve embodiment, it may additionally be considered to provide a cap that fits over the upper chamber lip 62 between uses.

Adapter valve 50 may be configured to function as a medicament adapter for intravenous infusion containers. In this case, the adapter valve 50 is placed on the medication container for intravenous infusion supply and attached to the intravenous delivery device via tubing. Thus, the adapter valve 50 is placed in fluid communication with the connector valve of FIG. 1 to facilitate the flow of medicament from the intravenous drip bottle.

An alternative embodiment of the seal, seal 36a, is shown in FIG. The seal 36a includes a seal cap 92 at its proximal end and a seal lip 96 at its distal end. A cup annular flange 95 is provided adjacent to the seal cap 92. The seal cap 92 and the seal lip 96 are connected by a seal wall consisting of a plurality of ring-shaped wall portions 94 that expand and fold in the form of accordion. During compression of the seal 36a, the diameter of the ring-shaped wall portion 94 expands radially outward. An air pocket 13a (see FIG. 10) is provided between the ring-shaped wall 94 and the housing, and an air pocket 13b is provided between the spike 24 and the seal 36a. The seal 36a includes a cavity 98 at the end of the seal cap 92 and adjacent the ring-shaped wall 94. Seal 36a interacts with spike 26 (see FIG. 2) and other components of the valve in a similar fashion to seal 36 of FIG.

Referring to FIG. 10, the cup annular flange 95 may extend around the upper conduit 20 and be held in place by the annular ring 97. This creates a trampoline effect that encourages the return of the seal 36a to the decompressed state after retraction (not shown) of the syringe. This embodiment has two advantages. First, the proximal end of valve 10 may be wiped with alcohol or other disinfectant without leakage of the disinfectant into the valve. Second, by attaching the cup annular flange 95 to the upper conduit 20 at its proximal end with an annular ring 97, iterative deformation and shape recovery of the seal 36a is encouraged.

In an alternative embodiment of the seal, the seal 36b is shown in connection with the valve 10 in FIG. The seal 36b is formed by the seal shown in Figs. 9 and 10, as the seal 36a is composed of a seal cap 92, a side wall made of a ring-shaped wall portion 94, and a seal lip 96. Similar to 36a).

The seal 36a also has an outwardly extending ring 99 perpendicular to the longitudinal axis of the valve 10. This ring 99 is used to attach the seal 36b to the upper conduit 20. Preferably, the upper conduit annular plug 20 'is inserted into the upper conduit 20 to provide a tight fit between the vertical ring 99 and the ledge 101 and the plug 20' in the upper conduit 20. Is inserted. The ring 99 helps to reconstruct the seal 36b to surround the spike 26 when withdrawing the syringe (not shown).

As shown in FIG. 12, both the cup-shaped annular flange 95 and the ring 99 can be used in conjunction with the valve 10 to provide a seal 36c. This seal 36c provides quick reconstruction when the syringe is withdrawn and realizes the advantages of the two seals 36a and 36b.

A seal 36d, which is another embodiment of the seal, is shown in FIG. In this embodiment, the seal 36d includes a seal cap 92, a seal lip 96, and sidewalls 150 of circular tires 100 successively stacked one on top of the adjacent large diameter lower tire. Include. The circular tire 100 is preferably solid over its cross sectional diameter. These circular tires 100 deform and reconstruct at the time of pressurization and decompression of the seal 36d, respectively, to expose or cover spikes (not shown) as the case may be.

As described above, the seal 36d preferably has a precut slit 11 in the cap 29 which lies along the longitudinal axis of the valve 10. The sealing cap 92 has a unique shape that ensures that the slit 11 is closed and sealed when withdrawing the syringe (not shown) and when reconstructing the seal 36d. It includes an enlarged internal pressure reaction member 200 that is integral with the sealing cap 92. Between the base end of the sidewall 150 and the member 200 is an annular space 102 filled with fluid in the cavity 98. This fluid receives pressure, for example the blood pressure of the patient to which the valve 10 is attached. In FIG. 14, a fluid, such as a patient's blood, flows through the aperture 34 of the spike 26 to fill the cavity 102. This hydraulic pressure pressurizes the outside of the member 200 to seal the slit 11 when the seal is depressurized as shown in FIGS. 14 and 19. The pressure from this fluid creates a high pressure seal that prevents the fluid from exiting the valve 10 through the slit 11. On the end of the member 200 is a semi-cylindrical annular burst ring 104 which advantageously extends the useful life of the seal 36d.

Preferably, the rupture ring 104 integrated with the member 200 is disposed along the circumference of the inner surface of the member 200, and a slightly dish-shaped pressure reducing portion 204 is disposed in the outer surface of the sealing body. In the depressurized state, the pressure reaction element seals any hole in the seal 36d to provide a nearly liquid tight seal while in the depressurized state. The pressure responsive member 200 allows the valve to remain in a liquid tight seal, even at very high pressures that can sometimes be experienced in medical devices, especially when the valve is connected to the patient's artery. The center of the member 200 and the annular space 102 is coaxial with the entry path 11a into the hole 11. The pressurized fluid fills the annular space 102 to apply pressure to press the member 200 to tightly seal the access path 11a into the hole 11. In a preferred valve embodiment, the distance from the ramp 11a to the base end of the sealing cap 92 is 1.27 to 0.19 cm (0.500 to 0.075 inch) and more preferably 0.25 cm (0.100 inch).

As best shown in Fig. 22, the tip 32 is designed to prevent breakage of the seal. Tip portion 32 has three sides 210, 212, 214 coupled to one another along separation lines a, b, and c. The combination of the three faces 210, 212, 214 will almost tear and break the seal 36d. This is avoided by providing dividers a, b, c arranged in recesses 220, 222, 224 to provide " embedded dividers ".

Another embodiment of the valve 10 using the seal 36d is shown in FIGS. 8 and 19-21. In this embodiment, the inner wall 160 of the upper end of the conduit 20 is provided with at least one, preferably a plurality of radial recesses 107. The recesses 107 are elongate and symmetrical with stars arranged generally parallel to the longitudinal axis of the valve 10. Each recess has an opposite lateral edge 162 that engages the seal 36d upon pressurization of the seal 36d. The recess provides space for the seal to expand upon pressing.

Another embodiment of the seal 36h is shown in FIGS. 23 and 25-27. In this embodiment, the seal 36h includes a seal cap 92 having a dish-shaped pressure reducing portion 204 (Fig. 23). The seal 36h has a distal end 11a at the base end adjacent to the pressure reducing part 204 and at the distal end of the sealing cap 92. In FIG. 23, a circular tire similar to the circular tire of FIG. 13 is provided. The seal 36h has an inner cavity 98. Also preferably the seal 36h has a sealing lip 96 as described in detail above.

As best shown in FIG. 8, the wall 181 of the proximal end of the upper conduit 20 is tapered inwardly at the same angle as in the nose 48 of the syringe 46. According to the ANSI standard, the taper is 0.006 inch / linear inch. The wall of the syringe nose 48 as the nose slides the opening 25a to push the seal 36h inward to pressurize the seal and cause the tip 32 of the spike 36 to enter the slit 11. 182 is supported against the wall 181. The seal 36d expands to almost completely fill the top of the recess 107 upon pressing. Some portions of the seal 36d are wedged between the edges 162, while others fill the recess 107. As the liquid flows through the nose 48 through the hole 34, air in the nose 48 is forced out of the nose 48 and expelled from the valve 10 between the walls 181, 182. Thus, nearly the entire prescription dose is delivered to the patient through valve 10. The fluid flows through the through hole 34 but does not leak between the seal 36d and the wall 181 or between the adjacent walls 181, 182.

15, 16, 17, and 18 show the seal 36a (FIG. 10), except that the sidewall 150 using the circular tire 100 is used in place of the accordion wall 94. An embodiment of a seal, i.e., seals 36e, 36f, 36g, substantially the same as 36b (Fig. 11) and 36c (Fig. 12) is shown.

Other components of the valve interact with the seals of the various embodiments in a manner similar to the interaction with the seal 36 of FIG. Prior to the use of the valve 10, preferably the sealing cap 40 or 92 is axially perforated by a steel needle in the axial direction to allow for faster decompression and reconstruction of the seal upon perforation by the spike 26. The seal is precut to provide the slit 11 for the purpose. The seal is advantageously formed of a material that can be repeatedly resealed and prevents fluid from flowing around the seal.

The seal 36 reappears back in place after exerting a downward force to reseal the valve. Too soft material does not effectively reseal, but does not recover again after opening the valve. Too hard material provides sufficient restoring force but does not seal effectively. Thus, in a preferred embodiment, the seal is formed from silicone having a hardness in the range of 30 to 70 Shore Durometer units, preferably 40 to 50 Shore Durometer units. Cured silicone polymers within the preferred hardness range are available from Wacker Silicone Corporation, Adrian, Michigan. In some valve embodiments, the seal 36 is provided with additional lubricity to allow it to be restored and more effectively resealed. Dow Chemical Corporation produces silicone tissue with silicone oils formed to provide these additional lubricating properties.

In general, the closing of the valve 10 fills the sealing cap 40, or the proximal ends of the cavity 98 and the opening 25a, rather than by the side wall of the seal 36 which immediately covers the through hole 34. Provided by a sealing cap 92. Thus, the sealing caps 40 and 92 are thick enough to effectively reseal the opening 25a after valve closing. However, the sealing caps 40, 92 should also be thin enough to allow them to easily return to the closed position. Preferably, the thickness of the caps 40, 92 is in the range of 0.1905 to 1.2700 cm (0.075 to 0.500 inch) and may preferably be about 0.2540 cm (0.1 inch).

The valve may be consumed after use in the provided mounting state and provided in sterile disposable form so that the device is discarded. However, as described above, in the provided mounting state, the valve can be reused many times. Since the valve does not use a needle, the device is inadvertently plugged into the skin. Therefore, it is not necessary to pay much attention to the handling and disposal of the needle. It will be apparent from the description provided herein that the valve can be provided for the removal of almost any needle used in the medical arts. With the use of the valves described above, the need for all needles is preferably eliminated except for placing them directly on the patient.

The valve 10 is used to provide a closed patient access system for administering a predetermined amount of medication to a patient from a remote source. The valve 10 is connected in fluid communication with the valve by the distal end to the patient, for example to a blood vessel or aorta. Blood fills the valve, but seal 36d prevents blood from leaking from the valve, for example. The transfer end or nose 48 of the medical equipment is inserted into the valve as shown in FIG. 8 to allow the tip 32 of the spike 24 to penetrate the seal and enter the transfer end. The nose 48 is pressed against the seal to sufficiently pressurize. The entirety of the medication may be transmitted through the nose 48 to the valve 10 and to the patient. The nose 48 and the seal 36d perforate the seal while at the same time avoiding the formation of the tip of the spike element 24 to avoid the formation of a rectangular space at the boundary between the nose 48 and the seal surface 40b. 32) combine in contact with the seal. The administration of a substantial total amount of medication through the valve 10 from the injector 46 to the patient is performed such that the predetermined amount is not collected in any rectangular space within the valve. Simultaneously withdrawing the nose 48 from the valve 10, the seal 36d returns to a compressed state to close the valve so that the fluid tightness during the compressed state remains high even after repeated use.

Another embodiment of the seal, seal 36h, is shown in FIG. In this embodiment, the seal 36h is the same as the seal 36d and one is stacked successively on top of the sealing cap 92, the sealing lip 96, and the upper diameter lower tie in contact with the seal 36d. Side wall 150 consisting of a circular tire 100. Sidewall 150 defines a cavity 98. Circular tires are preferably solid through the diameter of their cross section. These circular tires deform and reorganize upon compression and decompression of the seal 36h to expose or cover spikes (not shown) as if the case were present.

The sealing body 36h also has the slit 11 cut | disconnected previously in the sealing cap 92 which lies along the longitudinal axis of the sealing body 36h. The slit 11 remains sealed when the sealing body 36h is in a reduced pressure state. As already explained, the preliminary cutting of the seal to provide the slit 11 results in a faster depressurization and replacement of the seal upon perforation by the spikes. Unlike the seal 36d, however, the seal cap 92 of the seal 36h is substantially solid without the pressure response member as used in the seal cap 92 for the seal 36d. .

Another embodiment of the present invention using the seal 36h is shown in FIG. The spike 26a, which has a proximal end that stays in the cavity 98 and the tip 32 is embedded in the sealing cap 92, is shown to be a more tubular and worse truncated cone than the spike 26 shown in other embodiments. In addition, the tip 32 of spike 26a is a dull and rounded end, unlike the sharp tip of spike 26. Since the ends are rounded, the sealing cap is not adversely affected through tearing by the spike tip 32. Thus, for example, as shown in Fig. 14, a disassembly ring suitable for the seal is not necessary in this embodiment.

Another feature of this embodiment is the arrangement of the spikes 26a with the seal 36h when the seal 36h is in a reduced pressure state. In this state, the rounded tip 320 of the spike 36h is positioned to be embodied as the slit inlet 11a while the slit 11 remains closed for any fluid flow. A full rounded tip 32 is shown in contact with the distal end of 92. Additionally, the sidewall round tire, tire 100a, closer to the proximal end of the seal, contacts the sidewall of spike 26a. At least the next far-round tire, the tire 100b, also contacts the spike 26a proximate the through hole 34. A plurality of tires are in contact with the spike 26a proximate the through hole 34. Is prevented from penetrating the proximal end of the valve 10 from the cavity 98. Without this design, the fluid leaks through the through hole 34 and acts on the slit 11 to force the slit 11 to open. Whilst exerting sufficient hydraulic pressure on The seal remains in a reduced pressure state, so that the through hole 34 does not pressurize the slit 11 with the fluid passing through the through hole 34 and instead between the spike 26a and the seal 36h. It should be remote from the tires 100a and 100b in contact with the spikes 26a so as to be blocked by the circular tires 100a and 100b forming a seal thereon.

During drug application, for example when the valve 10 is connected to the patient's artery, the patient's blood flows through the aperture 34 in the spike 26a, thereby allowing the cavity 98 to be remote from the second tire 100b. ) Fills the area inside. Since the fluid present between the first two tires 100a and 100b and between the sealing cap 92 and the tire 100a consists of a very small volume, the fluid is opposed to the sealing cap to such an extent that it opens the slit 11. Not enough pressure to work. The precut seal cap 92 is designed to be present with the fluid pressure closed at up to 20 psi. Therefore, the blood pressure will not open the valve 10.

However, when connecting the distal end of the valve 10 to the patient's artery, as the blood is pushed against the seal 36h, the fluid moves the seal cap 92 in close proximity, thereby allowing the sidewall tire 100 to be moved. Press in the proximity direction. This pressurization causes the blood to flow past the tires 100a and 100b to pressurize the slit 11. However, due to the increased fluid pressure, the immediately adjacent distal first and second tires 100a, 100b of the tire move closely and contact the spikes 26a to take the initial positions of the tires 100a, 100b. The plurality of tires are always in contact with the spike 26a. Since the sidewall tire 100 of the seal 36h is designed to bend outwardly from the proximal end to the distal end, the immediately adjacent end tires 100a, 100b of the tire are not in contact with the spike 26a when in the initial position. You may not. However, as will be appreciated by those skilled in the art, fluid flows into the cavity 98 of the seal 36h through the spike 26a and the through hole 34 so that the seal 36h is in close proximity. Direction, the distal first tire 100a and the second tire 100b of the tire also move in the proximal direction and contact the spike 26a adjacent to the through hole 34 to contact the spike 26a and the seal. Strengthen the seal between 36h. That is, when no fluid is contained inside the cavity 98 of the valve 10, only the first tire 100a and the second tire 100b contact the spike 26a. However, once the fluid is introduced into the cavity 98 of the valve 10, the seal 36h can move in the proximal direction. If this occurs, in addition to the first tire 100a and the second tire 100b, the direct end second tire 100b of the tire is in contact with the seal 26a and between the seal 36h and the spike 26a. The seal cap 92 of the seal 36h by reinforcing the seal and preventing fluid from moving into the cavity 98 and past the tire 100 through the spikes 26a and through holes 34. To apply pressure to the slit (11).

Another embodiment of the housing, housing 12a, is shown in FIG. In this partial sectional view, the housing 12a is similar to the housing 12 except for the grooves 303 and 304 provided along the longitudinal axis of the inner wall of the upper conduit 20. The grooves 303, 304 are provided as fluid escape spaces such that a complete seal is not provided between the inner wall 305 of the upper conduit 20 and the seal cap 92. The grooves 303, 304 preferably extend away from the proximal end of the upper conduit 20 past the portion of the upper conduit 20 in contact with the seal cap 92. As best seen in FIG. 28, the groove 303 preferably extends away from the proximal end of the upper conduit 20 of the housing 12a to the proximal end of the radial indentation 107.

The provision of the fluid escape space provides the advantage that any fluid remaining in the space between the seal 36h and the upper conduit 20 exits the housing upon compression of the seal 36h. Referring to Figure 25, during normal use of the valve 10 in delivering fluid, the fluid penetrates into the portion of the housing 12a between the wall 305 of the upper conduit 20 and the seal 36h. can do. When this zone is filled with fluid and the seal cap 92 is compressed away by a medical instrument (not shown), the sidewall tire 100 is free of any space in the upper conduit 20 to be compressed due to the presence of the fluid. As no longer have, the user may have difficulty pressing the seal cap 92 far beyond the through hole 34 of the spike 26a. It is undesirable to require the user to apply a surplus force to compress the seal, because the user often twists the medical device downward onto the seal, causing degradation of the seal and eventually causing rupture. Because there is. In addition, the fluid between the inner wall 305 of the upper conduit 20 of the housing 12a and the seal 36h will prevent the seal 36h from compressing the through hole 34 of the spike 26a away. Can be. As a result, the valve 10 may not function properly.

By providing the grooves 303, 304, as the fluid exits the space, the fluid present between the inner wall 305 of the upper conduit 20 of the housing 12a and the seal 36h (not shown) In the compression of the seal 36h by the medical instrument, it can move closely through the grooves 303 and 304. As the fluid escapes from the valve 10 through the grooves 303, 304 at the proximal end of the housing 12a, the seal 36h can typically be compressed without the user of the valve 10 using excessive force. have.

FIG. 26A is a plan view of the valve shown in FIG. The grooves 303, 304 are shown in the upper conduit 20 of the housing 12a of the valve 10. Importantly, when the seal 36h is compressed away by a medical instrument (not shown), the seal 36h does not extend into the grooves 303 and 304 to prevent the flow of fluid through the groove. .

Another embodiment of the housing, housing 12b, is shown in FIG. Housing 12b employs channel 307 as a fluid escape space generally perpendicular to the longitudinal axis of valve 10. Channel 307 is a bore extending across the side of the wall of upper conduit 20, the bore being any luer lock screw 309 or other locking mechanism that can surround upper conduit 20 near the proximal end. Is located far away. Similar to the grooves 303, 304, the channel 307 seals 36 with the inner wall 305 of the upper conduit 20 when the sidewall tire 10 is compressed and expands into the radial indentation 107. It provides a passageway for the fluid in the zone to exit. Since there is a means for fluid to exit this zone, the user does not need to apply excessive force when pressing the medical instrument (not shown) far into the valve 10.

FIG. 26B is a plan view of the valve 10 shown in FIG. The channel 305 is shown in phantom and is preferably located in the upper conduit 20 of the housing 12b of the valve 10. Upon compression of the seal 36h by a medical instrument (not shown), the fluid between the upper conduit 20 and the seal 36h flows from the valve 10 through the channel 307 to the upper conduit 20. Escape outside the sidewalls. Thus, the channel 307 can be distinguished from the groove with respect to the groove 303 by the escape of fluid through the sidewall rather than the proximal end of the housing 12a.

As can be readily understood by one of ordinary skill in the art, the channels and grooves can be combined and incorporated to help escape fluid from the valve upon compression of the seal by the medical device. For example, upon compression of the seal, the fluid may move closely through the groove and then move through the channel in communication with the groove. The channel may be located far from the proximal end of the valve. Moreover, as will be readily appreciated by those skilled in the art, a single groove or channel may be used or a plurality of grooves or channels may be incorporated into the valve of the present invention.

Without the channels or grooves discussed above, it may lead to deterioration of the seal 36 and prevent the seal cap 92 from being fully pressurized under the through hole 34. If the through hole is not fully open, the patient will not be able to receive a certain amount of drug. In some situations, dispensing the correct amount of drug at a set rate can be important for treatment, so the through hole 34 must be fully open for passage of the drug from the medical device. The grooves and / or channels ensure that the seal cap is pressed away from the through hole and that the seal is compressed without any excessive force that may cause damage to the seal.

Claims (6)

A body having a wall structure defining an interior cavity and having a proximal end and a distal end, the proximal end having an opening large enough to receive a tip of a dispensing end of a medical instrument for delivering fluid therethrough; A spike having a tip received in the cavity and disposed away from the tip and having a passageway in communication with the aperture to allow fluid to flow through the spike; Surrounds the spike within the cavity and is adapted to move in a compressed state when inserting the tip of the medical instrument into the opening and have sufficient elasticity to return to a depressurized state when removing the tip of the medical instrument from the opening. And an elastic seal having at least two tires in contact with the spike proximate to the aperture to prevent penetration of fluid through the valve when in a reduced pressure. The fluid of claim 1, wherein the fluid exerts a low first pressure on the seal and when the fluid exerts a high second pressure on the seal, at least one other tire is applied to the spike proximate the aperture. Characterized in that it is brought into contact. A body having an internal cavity having a proximal end and a distal end, the proximal end having an opening large enough to receive a dispensing end of a medical device for delivering fluid therethrough, a spike disposed within the cavity, and within the cavity of the body; An elastic seal disposed between the body and the spike, the spike having a spike tip at its proximal end and at least one hole disposed away from the spike tip to allow fluid to flow through the spike; And the seal is configured to transfer fluid through a medical valve having at least one tire in contact with the spike proximate the aperture to prevent fluid from flowing through the valve when the seal is in a reduced pressure. In A) inserting the tip of the medical instrument into the opening in the proximal end of the body; B) compressing the seal in the distal direction by applying force to the medical device; C) placing the aperture and the medical instrument in fluid communication; D) delivering the fluid through the medical valve; E) removing the medical instrument from the opening in the proximal end of the body, and F) causing the tire to contact the spike proximate the aperture to prevent flow of fluid through the valve. The method of claim 3, wherein the step b) is performed after the step e). 4. The method of claim 3, wherein the step of bar comprises bringing at least two tires into contact with the spikes proximate the aperture. 4. The method of claim 3, wherein in step bar) the fluid exerts a low first pressure on the seal, The method again G) exerting a high second pressure on the seal and causing at least one other tire to contact the spike proximate the aperture.